Alcon · 2 days ago

Senior Quality Engineer I - Complaints

Sinking Spring, PA

Full-time

Onsite

Senior Level

2+ years exp

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Responsibilities

Investigate customer complaints to determine the root cause

Maintain knowledge of product quality controls and failure modes

Uses various statistical and non-statistical problem-solving tools as part of the analysis of data, issues, or improvement opportunities

Contribute to the continued alignment of local, global, and industry standards/regulations including cGMPs & ISO standards

Support the reduction of recurring nonconformance events

Provide Progress Reports and trending to show product quality levels and respond to regulatory requests and critical issue events

Provide complaint trending analyses to support the improvement of products manufactured in the facility and prepare trend reports for the site Complaint Review Board and Post Product Risk Activities.

Actively participate and contribute to routine platform-based meetings and change control activities

Identify and Support improvement efforts within the complaint-handling process

Provide day-to-day mentoring, assistance, and support to Complaint Department QE/s, QE Techs

Perform quality approval on SOPs, specifications, preventative maintenance, and training documents

Complete GAP analysis against local, global, and industry standards, as needed, and lead or support development/execution of actions to close gaps

Qualification

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English ProficiencyRelevant ExperienceCommunicationProject ManagementITrackSAP